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Seagen's (SGEN) Tisotumab Vedotin BLA Gets FDA Priority Review
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Seagen Inc. , along with its Danish partner Genmab A/S (GMAB - Free Report) , has announced that the FDA has accepted the biologics license application (“BLA”) for investigational antibody drug conjugate, tisotumab vedotin, for the treatment of recurrent or metastatic cervical cancer in patients whose disease progressed on or after chemotherapy.
With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on Oct 10, 2021.
In February this year, Seagen and Genmab submitted the BLA to the FDA for the accelerated approval of tisotumab vedotin.
The BLA was based on data from the pivotal phase II innovaTV 204 study, which evaluated tisotumab vedotin as a monotherapy for the given indication. Data from the same showed that treatment with tisotumab vedotin led to clinically meaningful and durable responses in this difficult-to-treat cervical cancer patient population.
Per the company, cervical cancer remains one of the leading causes of cancer death in women with more than 311,000 women dying annually from the disease throughout the world. Hence, if approved, tisotumab vedotin as monotherapy might become an important treatment option for women with recurrent or metastatic cervical cancer, who have experienced disease progression on or after chemotherapy.
Shares of Seagen have declined 18.5% so far this year compared with the industry’s decrease of 6.7%.
We remind investors that Seagen is developing tisotumab vedotin in collaboration with Genmab. The companies share all costs and profits equally for the product.
In January 2021, Genmab initiated the phase III innovaTV 301 study, which is evaluating tisotumab vedotin as compared to chemotherapy for treating recurrent/metastatic cervical cancer in patients who have received one or two prior lines of systemic therapy.
Apart from cervical cancer, tisotumab vedotin is being investigated as monotherapy in a range of solid tumors, including ovarian cancer, and in combination with commonly used therapies for metastatic cervical cancer.
Seagen’s portfolio currently comprises three marketed drugs, namely - Adcetris, Padcev and Tukysa, which are approved for different cancer indications. The company generated net revenues of $2.2 billion in 2020, reflecting significant growth year over year. A potential approval for tisotumab vedotin will add a fourth drug to Seagen’s portfolio, which should drive growth for the company in 2021 and beyond.
Repligen’s earnings estimates have been revised 15.1% upward for 2021 and 9.8% upward for 2022 over the past 60 days. The stock has increased 7.5% year to date.
Nabriva’s loss per share estimates have narrowed 45.8% for 2021 and 50.9% for 2022 over the past 60 days.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
Image: Bigstock
Seagen's (SGEN) Tisotumab Vedotin BLA Gets FDA Priority Review
Seagen Inc. , along with its Danish partner Genmab A/S (GMAB - Free Report) , has announced that the FDA has accepted the biologics license application (“BLA”) for investigational antibody drug conjugate, tisotumab vedotin, for the treatment of recurrent or metastatic cervical cancer in patients whose disease progressed on or after chemotherapy.
With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on Oct 10, 2021.
In February this year, Seagen and Genmab submitted the BLA to the FDA for the accelerated approval of tisotumab vedotin.
The BLA was based on data from the pivotal phase II innovaTV 204 study, which evaluated tisotumab vedotin as a monotherapy for the given indication. Data from the same showed that treatment with tisotumab vedotin led to clinically meaningful and durable responses in this difficult-to-treat cervical cancer patient population.
Per the company, cervical cancer remains one of the leading causes of cancer death in women with more than 311,000 women dying annually from the disease throughout the world. Hence, if approved, tisotumab vedotin as monotherapy might become an important treatment option for women with recurrent or metastatic cervical cancer, who have experienced disease progression on or after chemotherapy.
Shares of Seagen have declined 18.5% so far this year compared with the industry’s decrease of 6.7%.
We remind investors that Seagen is developing tisotumab vedotin in collaboration with Genmab. The companies share all costs and profits equally for the product.
In January 2021, Genmab initiated the phase III innovaTV 301 study, which is evaluating tisotumab vedotin as compared to chemotherapy for treating recurrent/metastatic cervical cancer in patients who have received one or two prior lines of systemic therapy.
Apart from cervical cancer, tisotumab vedotin is being investigated as monotherapy in a range of solid tumors, including ovarian cancer, and in combination with commonly used therapies for metastatic cervical cancer.
Seagen’s portfolio currently comprises three marketed drugs, namely - Adcetris, Padcev and Tukysa, which are approved for different cancer indications. The company generated net revenues of $2.2 billion in 2020, reflecting significant growth year over year. A potential approval for tisotumab vedotin will add a fourth drug to Seagen’s portfolio, which should drive growth for the company in 2021 and beyond.
Zacks Rank & Stocks to Consider
Seagen currently carries a Zacks Rank #4 (Sell). Better-ranked stocks in the biotech sector include Repligen Corporation (RGEN - Free Report) and Nabriva Therapeutics AG , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates have been revised 15.1% upward for 2021 and 9.8% upward for 2022 over the past 60 days. The stock has increased 7.5% year to date.
Nabriva’s loss per share estimates have narrowed 45.8% for 2021 and 50.9% for 2022 over the past 60 days.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>